510(k) K894894 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ANTI-SM MICROASSAY
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Aug 24, 1989 |
| Received | Aug 1, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894894
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.